I totally agree that project managers (PMs) aren’t traditional leaders but more like advisors or facilitators. They don’t make the actual decisions they just bring together different departments, align goals with the company’s interests, and make sure everything runs smoothly….   Read more»

I totally agree! Being in the same group, I think our approach worked really well because we took everyone’s ideas into account. Since all of our perspectives were valid, we decided to rank them based on feasibility and potential impact….   Read more»

I totally agree that testing conditions play a huge role in verification failures, and sometimes, the issue isn’t the design itself but how the test is set up. The temperature factor is a big one—37°C is definitely going to affect…   Read more»

If we could change the DSD, rather than the verification test. Our strategy would be different. As the DSD specifies product specs, we could tweak bigger aspects of the product. We could change the adhesive formula, the surface treatment, and…   Read more»

The Design Input Document (DID) and Design Specification Document (DSD) are both very important elements of the PDCA (Plan-Do-Check-Act) cycle, but it has an underlying reason for maintaining them separately. The DID records the general requirements and expectations of the…   Read more»

In order to create a robust final product, it is important to understand the worst-case scenario outcomes. If a product undergoes rigorous testing of worst-case scenarios, it will be assumed to last under less severe and more realistic conditions. In…   Read more»

I completely agree with your perspective that the Design History File (DHF) should be treated as an active part of the product development process rather than an afterthought. Maintaining a well-organized DHF not only helps meet FDA regulatory requirements but…   Read more»

The verification failure shows the importance of integrating a strong risk management framework and focusing on continuous improvement in medical device projects. Conducting a FMEA early in the design process is a way to predict and plan for risks before…   Read more»

The Design Input Document (DID) outlines the user needs, regulatory requirements, and functional expectations for a medical device. It serves as the foundation for the design process, ensuring that all critical aspects such as safety, usability, and performance are considered….   Read more»

Risk mitigation and continuous improvement in a medical device project are essential for ensuring safety, compliance, and effectiveness. Identifying potential risks early through hazard analysis and failure mode assessment helps prevent costly errors. Implementing robust quality control measures and adhering…   Read more»

Managing problem-solving on diverse teams requires fostering an inclusive environment where all perspectives are valued. Leaders should encourage open communication and active listening to ensure team members feel heard. Emphasizing shared goals helps align diverse viewpoints toward a common purpose….   Read more»

The DHF should be treated as an essential asset for quality control of the design controls process since it is the set of documents ensuring compliance with regulatory requirements to support continuous improvement of design controls. At the same time,…   Read more»

We faced the same situation in my team. I noticed that the difference in our background led us to some interesting discussions about what could be causing the label failure. Initially, we struggled a bit because different people had different…   Read more»

Testing should strike a balance between worst-case scenarios and real-world usage conditions. While extreme conditions help define the absolute limits of a product’s durability, they may not always reflect how the product will actually be used. If a test is…   Read more»

As has already been discussed, I agree that it’s important to test a variety of conditions. This way, you can mimic more common/ “real world” settings and also test the limits of the product. With that being said, in the context…   Read more»